Catalog Number

-

Brand Name

Vortex

Version/Model Number

044F7247

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

d2ae608a-0ce9-4c18-a029-09da876b23e3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 17, 2016

Package DI Number

00744229100539

Quantity per Package

12

Contains DI Package

00744229440611

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton